Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines Second Edition

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines Second Edition – Ebook Instant Download/Delivery ISBN(s): 9780128042175,0128042176,9780128042588, 0128042583

Product details:

• ISBN-10: 0128042583
• ISBN-13: 9780128042588
• Author: Brody Tom

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.

Table contents:

Chapter 1. Origins of Drugs

Chapter 2. Clinical Trial Design

Chapter 3. Run-In Period

Chapter 4. Inclusion/Exclusion Criteria, Stratification, and Subgroups—Part I

Chapter 5. Inclusion/Exclusion Criteria, Stratification, and Subgroups—Part II

Chapter 6. Blinding, Randomization, and Allocation

Chapter 7. Placebo Arm as Part of Clinical Trial Design

Chapter 8. Intent-to-Treat Analysis Versus Per Protocol Analysis

Chapter 9. Biostatistics—Part I

Chapter 10. Biostatistics—Part II

Chapter 11. Introduction to Endpoints

Chapter 12. Oncology Endpoint—Objective Response

Chapter 13. Oncology Endpoints: Overall Survival and Progression-Free Survival

Chapter 14. Oncology Endpoints: Time to Progression

Chapter 15. Oncology Endpoint: Disease-Free Survival

Chapter 16. Oncology Endpoint: Time to Distant Metastasis

Chapter 17. Neoadjuvant Therapy Versus Adjuvant Therapy

Chapter 18. Hematological Cancers

Chapter 19. Biomarkers

Chapter 20. Endpoints for Immune Diseases

Chapter 21. Endpoints for Infections

Chapter 22. Health-Related Quality of Life Tools—Oncology

Chapter 23. Health-Related Quality-of-Life Tools—Immune Disorders

Chapter 24. Health-Related Quality-of-Life Tools—Infections

Chapter 25. Drug Safety

Chapter 26. Mechanism of Action of Diseases and Drugs—Part I

Chapter 27. Mechanism of Action—Part II (Cancer)

Chapter 28. Mechanism of Action—Part III (Immune Disorders)

Chapter 29. Mechanisms of Action—Part IV (Infections)

Chapter 30. Consent Forms

Chapter 31. Package Inserts

Chapter 32. Warning Letters

Chapter 33. Regulatory Approval

Chapter 34. Patents

People also search:

clinical trials near me

fenbendazole cancer clinical trials

phases of clinical trials

clinical trials day

paid clinical trials

fortrea clinical trials

regrow teeth clinical trials